Actively Recruiting
Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
Led by Omeros Corporation · Updated on 2025-07-15
20
Participants Needed
6
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)
CONDITIONS
Official Title
Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults 18 years and older
- Able to provide informed consent
- Diagnosis of C3 Glomerulopathy (including dense deposit disease) or Idiopathic Immune Complex-Mediated Glomerulonephritis confirmed by biopsy within 36 months
- Two 24-hour urine protein-to-creatinine ratios of 0.8 gm/gm or higher, collected 14 to 28 days apart
- Estimated glomerular filtration rate (GFR) of 45 mL/min/1.73 m2 or higher
- Serum C3 concentration below the laboratory's lower normal limit
- Stable maximally tolerated or allowed dose of ACE inhibitor or ARB for at least 90 days
- If using sodium-glucose co-transporter-2 (SGLT-2) inhibitors, stable dose for at least 90 days
- If using mycophenolate mofetil, mineralocorticoid receptor antagonist, or corticosteroids, stable dose for at least 90 days
- Current vaccination for Neisseria meningitidis, Streptococcus pneumonia, and Haemophilus influenza, and agreement to maintain vaccination during the study
- Female patients of child-bearing potential must have a negative pregnancy test at screening and before each dose
- Females must use highly effective birth control during the trial and for 20 weeks after last dose
- Males must use highly effective birth control with a female partner during the trial and for 20 weeks after last dose
You will not qualify if you...
- History of major organ transplant or hematopoietic stem cell/marrow transplant
- Known congenital deficiency of complement factors C1q, C1r, C1s, C2, or C4
- Rapidly progressing glomerulonephritis with 50% or more decline in eGFR within 3 months and glomerular crescent formation in at least 50% of glomeruli
- Renal biopsy showing interstitial fibrosis/tubular atrophy over 50%
- Immunodeficiency or immunosuppressive treatment (except specific stable doses) within 90 days of screening
- Rituximab treatment within 6 months prior to screening
- Resting blood pressure over 140/90 mmHg during screening
- Active malignancy within 5 years except non-melanoma skin cancers
- History of monoclonal gammopathy of unknown significance or autoimmune disorder
- Elevated liver enzymes or bilirubin beyond defined limits
- Severe hypersensitivity to monoclonal antibodies or OMS906 components
- Significant active bacterial or viral infection within 2 weeks prior to screening
- Use of other complement inhibitors within 6 months before screening
- HIV, hepatitis B, or untreated hepatitis C infection
- Pregnant, planning pregnancy, or nursing
- Recent surgery requiring general anesthesia within 2 weeks before screening or planned during treatment
- Significant medical, neurological, or psychiatric disorders making participation unsuitable
- Use of investigational drugs or devices within 30 days or 5 times their half-life prior to screening
- Unable or unwilling to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Omeros Investigational Site
Kaunas, Lithuania
Actively Recruiting
2
Omeros Investigational Site
Vilnius, Lithuania
Actively Recruiting
3
Omeros Investigational Site
Auckland, New Zealand
Actively Recruiting
4
Omeros Investigational Site
Lodz, Poland
Actively Recruiting
5
Omeros Investigational Site
Leicester, United Kingdom
Actively Recruiting
6
Omeros Investigational Site
Newcastle upon Tyne, United Kingdom
Actively Recruiting
Research Team
O
Omeros Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here